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European LeukemiaNet recommendations for the management and avoidance of adverse events of treatment in chronic myeloid leukaemia


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#1 gerry

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Posted 29 December 2016 - 05:15 PM

Abstract

Most reports on chronic myeloid leukaemia (CML) treatment with tyrosine kinase inhibitors (TKIs) focus on efficacy, particularly on molecular response and outcome. In contrast, adverse events (AEs) are often reported as infrequent, minor, tolerable and manageable, but they are increasingly important as therapy is potentially lifelong and multiple TKIs are available. For this reason, the European LeukemiaNet panel for CML management recommendations presents an exhaustive and critical summary of AEs emerging during CML treatment, to assist their understanding, management and prevention. There are five major conclusions. First, the main purpose of CML treatment is the antileukemic effect. Suboptimal management of AEs must not compromise this first objective. Second, most patients will have AEs, usually early, mostly mild to moderate, and which will resolve spontaneously or are easily controlled by simple means. Third, reduction or interruption of treatment must only be done if optimal management of the AE cannot be accomplished in other ways, and frequent monitoring is needed to detect resolution of the AE as early as possible. Fourth, attention must be given to comorbidities and drug interactions, and to new events unrelated to TKIs that are inevitable during such a prolonged treatment. Fifth, some TKI-related AEs have emerged which were not predicted or detected in earlier studies, maybe because of suboptimal attention to or absence from the preclinical data. Overall, imatinib has demonstrated a good long-term safety profile, though recent findings suggest underestimation of symptom severity by physicians. Second and third generation TKIs have shown higher response rates, but have been associated with unexpected problems, some of which could be irreversible. We hope these recommendations will help to minimise adverse events, and we believe that an optimal management of them will be rewarded by better TKI compliance and thus better CML outcomes, together with better quality of life.

http://www.nature.co...eu2016104a.html (thanks Josie)



#2 kat73

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Posted 29 December 2016 - 05:47 PM

I couldn't get this - says page not available. Anything I can do?

 

Laughed right out loud at that quiet phrase about imatinib:  "recent findings suggest underestimation (italics mine) of symptom severity by physicians."  No s---, Sherlock! 


Dx July 2009 on routine physical.  WBC 94.  Started Gleevec 400 mg Sept 2009.  MMR at 2yrs.  Side effects (malaise, depression/anxiety, fatigue, nausea, periorbital edema) never improved.  Kidney issues developed because of Gleevec.  Switched to Sprycel 70 mg in Aug 2011.  Above side effects disappeared or improved.  Have been MR3.5 - 4.5 ever since.  Two untreated pleural effusions followed by one treated by stopping Sprycel Jan 2017.  After 9 weeks, PCR showed loss of MMR; re-started Sprycel at 50 mg and in 3 months was back to <0.01% IS.  Pleural effusion returned within a couple of months, same as before (moderate, left side only).  Stopped Sprycel 50 mg for 12 weeks; pleural effusion resolved.  At about a monthoff the drug, PCR was 0.03; at 11 weeks it was 2.06 - lost CCyR? Have returned to 50 mg Sprycel for 3 weeks, intending to reduce to 20 mg going forward.


#3 jjg

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Posted 29 December 2016 - 06:35 PM

http://www.nature.co...eu2016104a.html


Dx Dec 2010 @37

2x IVF egg collection

Glivec 600 & 800mg

PCRU March 2012

Unsuccessful pregnancy attempt - relapsed, 3 months interferon (intron A), bad side effects from interferon

Nilotinib 600mg Oct 2012

PCRU April 2013, 2 years MR4.5 mostly PCRU with a few blips

April 2015 stopped again for pregnancy attempt (donor egg), pregnant first transfer, 0.110 at 10wks, 2.1 at 14wks, 4.2 at 16wks, started interferon, slow dose increase to 25MIU per wk, at full dose PCR< 1 for remainder of pregnancy

Healthy baby girl Jan 2016, breastfed one month

Nilotinib 600mg Feb 2016

MMR May 2016

PCRU Feb 2017


#4 gerry

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Posted 29 December 2016 - 09:05 PM

Thanks Josie - put the link in while on my phone, didn't think to check it. 



#5 kat73

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Posted 30 December 2016 - 12:31 PM

Thanks for the new link.  So interesting and helpful!  Once again, however, I'm dismayed to find there is no mention of depression, anxiety or brain fog, things that a lot of us have complained about.  So many of us date these troubles to the start of taking TKI's.  I thought it was being looked into.  Guess not.  They don't believe us - the old mind/body split strikes again.  The brain is an organ like the liver, kidneys, heart - all the things they do mention.  Some of the incidences of the symptoms associated with these are extremely small - so, the numbers for depression are small, but are they any less plausible?


Dx July 2009 on routine physical.  WBC 94.  Started Gleevec 400 mg Sept 2009.  MMR at 2yrs.  Side effects (malaise, depression/anxiety, fatigue, nausea, periorbital edema) never improved.  Kidney issues developed because of Gleevec.  Switched to Sprycel 70 mg in Aug 2011.  Above side effects disappeared or improved.  Have been MR3.5 - 4.5 ever since.  Two untreated pleural effusions followed by one treated by stopping Sprycel Jan 2017.  After 9 weeks, PCR showed loss of MMR; re-started Sprycel at 50 mg and in 3 months was back to <0.01% IS.  Pleural effusion returned within a couple of months, same as before (moderate, left side only).  Stopped Sprycel 50 mg for 12 weeks; pleural effusion resolved.  At about a monthoff the drug, PCR was 0.03; at 11 weeks it was 2.06 - lost CCyR? Have returned to 50 mg Sprycel for 3 weeks, intending to reduce to 20 mg going forward.


#6 gerry

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Posted 30 December 2016 - 03:24 PM

Brain fog is definitely real. I only started to get it towards the end of my being on Gleevec. Was forgetting names, words appointments. It was the first side effect that disappeared. I actually felt that my head was clearer.

#7 tiredblood

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Posted 30 December 2016 - 08:32 PM

I'm glad you mentioned brain fog. I think I've had less of it since switching from Tasigna to gleevec.

#8 gerry

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Posted 03 January 2017 - 12:26 AM

This is an English article

 

Safety Data for TKI Cessation Emerges for Chronic Myeloid Leukemia - See more at: http://www.curetoday....fkJ38032.dpuf 

 

 

"We already have a number of patients who have gone on reduced therapy because of side effects. You're looking to get balance between response and minimization of side effects. So, in some patients, we're already doing this," Copland said. "This will be more widely adopted, now that we know that for patients who are responding we can safely reduce therapy." Based on the findings from the EURO-SKI trial along with supporting evidence from DESTINY and other studies, Mahon feels confident that TKI cessation will soon be incorporated into various treatment guidelines for CML. He plans to propose the addition of TKI cessation to the European Leukemia Net guidelines in early 2017. -






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